NCT00939835

Study Comparing Citalopram Hydrobromide Tablets 40 mg (Torrent Pharmaceuticals Ltd) and RLD Tablets 40 mg (Manufactured By Forest Pharmaceuticals Inc, Missouri) in 24+2 Normal Healthy Male Subjects in Fed Condition

A Randomized, Single Dose, Open Label, Bioequivalence Study Comparing Citalopram Hydrobromide Tablets 40 mg (Torrent Pharmaceuticals Ltd) and RLD Tablets 40 mg (Manufactured By Forest Pharmaceuticals Inc, Missouri) in 24+2 Normal Healthy Male Subjects in Fed Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Torrent Pharmaceuticals Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: —

Summary

* Objective: * The objective of this study is to compare the rate and extent of absorption of the Test Product, Citalopram Hydrobromide 40 mg (Torrent Pharmaceutical Limited) to the Reference Product, RLD Tablets 40 mg (Forest Pharmaceuticals Inc, Missouri) under fed condition * Study Design: * Randomized, Single Dose, Open Label, Non-Replicate, Two-period, Two-treatment, Two- Sequence Crossover Bioequivalence Study comparing Citalopram Hydrobromide Tablets 40 mg (manufactured by Torrent Pharmaceuticals Ltd). With RLD Tablets 40 mg (manufactured by Forest Pharmaceuticals Inc Missouri) in 24+2 normal healthy male subjects with a wash out period of 15 days between the two study periods, in fed condition.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Citalopram Hydrobromide

Timeline

• First posted: 2009-07-15
• Last updated: 2017-10-24

Locations

1 site across 1 country: India